MAUDE Adverse Event Report: EBI, LLC. SPINALPAK STIMULATOR, BIOMET; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: the event occurred sometime in (b)(6) 2019.Concomitant medical products: medical product: l5 screw.Therapy date: unknown.The customer has indicated that the product will not be returned to zimmer biomet for investigation because the patient may still use the unit.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device has not been returned.
Event or Problem Description
It was reported that the patient was experiencing pain from using the spinalpak stimulator.The pain started a week after using the unit.The pain is on the lumbar area going down to the buttocks and the pain is below the skin.The patient stated that she feels like she is carrying extra weight.The patient says that the pain level is at a 10.The patient stopped her physical therapy as it was causing her pain.The patient scheduled an appointment with her physician.The patient went to her pain management doctor and was prescribed medication.The patient was previously on this medication but was easing off of it.The patient is no longer using the stimulator until her doctor appointment.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device was not returned to zimmer biomet for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections have been updated: b4: date of this report added.B5: event description updated.B7: relevant history added.G4: date received by manufacturer added.G7: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: method code updated to 3331: analysis of production records.H6: method code updated to 4114: device not returned.H6: results code updated to 3221: no findings available.H6: conclusions code updated to 4315: cause not established.H10: additional narratives/data.
Event or Problem Description
It was reported that the patient was experiencing pain from using the spinalpak stimulator.The pain started a week after using the unit.The pain is on the lumbar area going down to the buttocks and the pain is below the skin.The patient stated that she feels like she is carrying extra weight.The patient says that the pain level is at a 10.The patient stopped her physical therapy as it was causing her pain.The patient went to her pain management doctor and was prescribed medication.The patient was previously on this medication but was easing off of it.The patient saw her surgeon and was told to continue use of the spinalpak stimulator and was prescribed pain medication.It was reported that no further information is available.

• Brand Name: SPINALPAK STIMULATOR, BIOMET
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 9459692
• Report Number: 0002242816-2019-00047
• Device Sequence Number: 2159839
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1067717
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention